Gemcitabine

Product NDC

60505-6113

11-digit product format

605056113

Labeler code

60505

Product ID

60505-6113_22629a2c-90ab-6746-fe2a-5909ceb6f946

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

GEMCITABINE HYDROCHLORIDE

Dosage form

INJECTION, SOLUTION

Route

INTRAVENOUS

Labeler

Apotex Corp.

Application

ANDA206776

Marketing category

ANDA

Marketing start

2018-03-20

Marketing end

2021-01-31

Substance

GEMCITABINE HYDROCHLORIDE

Active strength

38 mg/mL

Pharmacologic classes

Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record